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Observational Study
. 2022 Jan;80(2):397-406.
doi: 10.1111/his.14562. Epub 2021 Nov 11.

Evaluating programmed death-ligand 1 (PD-L1) in head and neck squamous cell carcinoma: concordance between the 22C3 PharmDx assay and the SP263 assay on whole sections from a multicentre study

Bruna Cerbelli  1 , Ilaria Girolami  2 , Albino Eccher  3 , Leopoldo Costarelli  4 , Silvia Taccogna  5 , Renzo Scialpi  6 , Maria Benevolo  7 , Teresa Lucante  8 , Piero Luigi Alò  9 , Francesca Stella  10 , Maria Gemma Pignataro  11 , Guido Fadda  12 , Giuseppe Perrone  13 , Giulia D'Amati  11 , Maurizio Martini  14
Affiliations
Observational Study

Evaluating programmed death-ligand 1 (PD-L1) in head and neck squamous cell carcinoma: concordance between the 22C3 PharmDx assay and the SP263 assay on whole sections from a multicentre study

Bruna Cerbelli et al. Histopathology. 2022 Jan.

Abstract

Aims: The introduction of immunotherapy for patients with head and neck squamous cell carcinoma (HNSCC) raises the need for harmonisation between different types of antibody and immunohistochemistry platform for evaluating the expression of PD-L1 by use of the combined positive score (CPS) in this tumour. The aim of this study was to compare the expression of PD-L1 as determined with the CPS and two widely used assays (the 22C3 PharmDx assay and the SP263 assay) in a cohort of HNSCCs.

Methods and results: We analysed 43 whole sections of HNSCC with two different anti-PD-L1 antibodies, 22C3 and SP263. The results, expressed as the CPS, were evaluated by 10 trained pathologists and statistical analyses were performed. We found a very similar results for PD-L1 expression between the 22C3 PharmDx assay and the SP263 assay in our cohort, and a strong and significant correlation between the two assays for all specimens (P < 0.0001). The interobserver reliability among pathologists for the continuous scores of CPS with the intraclass correlation coefficient and the correlation between the two assays were both good. Moreover, the rate of agreement between assays was high at all cut-offs and was best for the most relevant cut-off of CPS ≥ 1, and the kappa values were always in the range of almost perfect.

Conclusions: Two different assays (the 22C3 PharmDx assay and SP263 assay) for PD-L1 in HNSCC showed high agreement. These data suggest that these two assays are interchangeable in the selection of patients with HNSCC for immunotherapy.

Keywords: 22C3 assay; PD-L1; SP263 assay; head and neck squamous carcinoma.

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Conflict of interest statement

The authors declare that they have no conflicts of interest.

Figures

Figure 1
Figure 1
Two head and neck squamous cell carcinoma samples (A, D, haematoxylin and eosin) analysed with the 22C3 PharmDx assay (B, E) and the SP263 assay (C, F). Programmed death‐ligand 1 expression as determined with the 22C3 and SP263 antibodies shows similar combined positive score (CPS) values in the two cases (A–C, CPS ≥ 20; D–F, CPS < 20).
Figure 2
Figure 2
The boxplot of the distribution of programmed death‐ligand 1 combined positive score (CPS) values (clear box for 22C3 and coloured box for SP263) for all samples. The smallest value and the largest value are at the ends of the ‘whiskers’, and the interquartile range is the box. The two dotted lines in the plot indicate CPS cut‐offs of 1 (near the y‐axis) and 20.
Figure 3
Figure 3
A, The direct and significant correlation between the combined positive score (CPS) evaluated with the 22C3 antibody and the SP263 antibody (Spearman r = 0.945; P < 0.0001). B, The distribution of programmed death‐ligand 1 expression as determined with the the 22C3 PharmDx assay kit and the SP263 assay for the CPS.
See this image and copyright information in PMC

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